Ashwagandha: Effects on Stress, Inflammation and Immune Cell Activation

March 17, 2010 updated by: National University of Natural Medicine
Ayurvedic medicine has been practiced in for more than 2,500 years. Ashwagandha is one of the most widely utilized herbs in the system. It is thought to affect the endocrine, immune, nervous, and cardiopulmonary systems. This study is designed as a preliminary investigation of the effects of Ashwagandha on stress, inflammation, and immune modulation. Participants will take the liquid extract in cow's milk twice a day for five days. The results of initial, one-day, and final blood draws will be compared to determine participant's beginning and ending levels of cortisol, inflammatory cytokines, and immune-cell activation (CD4 T-cells, CD8 T-cells, B cells and natural killer cells). Measurements will be completed using flow cytometry and ELISA assay. The purpose of this study is to determine which effects of Ashwagandha are most suitable for further investigation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Due to the increased use of alternative medicine, supplements and herbs are consumed more frequently in the treatment of common ailments. This pilot study investigates the immune, anti-inflammatory and anti-stress effects of Ashwagandha in human subjects.

Liquid extract of the herb will be taken followed by milk; this mode of administration will be used as it approximates the traditional administration as well as making self administration easier for participants. Extract will be taken in 3 milliliter quantities 2 times per day, (morning and evening), for five days. Total dosage of 6 milliliters will approximate the higher end of the traditional daily dosage of 6 grams daily of powdered root.

Flow of visit:

25 participants will arrive at the research lab and after being consented, filling out health histories and two stress questionnaires, (POMS and STAI Self-Evaluation), average milk intake questionnaire. The 25 participants will receive blood draws. They will then be administered the herb extract, milk and instructions for taking them.

Subjects will return to the research institute after 24 hours for a second blood draw and then after 5 days for a final blood draw and two more stress questionnaires, (POMS and STAI Self-Evaluation).

Once the blood samples are drawn, they will be refrigerated and processed within 24 hours at the NCNM laboratory. Initially they will be centrifuged to separate the white from the red blood cells using Ficoll separating tubes. Then the white blood cells will be stained using CD69 marker (Cytokine Detection type 69) which assesses cell-surface phenotypic markers in combination with intracellular cytokines, measuring response to activation. It is especially effective for rare-event, antigen-specific events, such as the administration of a specific immune-stimulating herbal tincture. We will also stain with other similar florescent CD markers specific for CD4 T-cells, CD8 T-cells, B-cells, NK cells, and macrophages. These markers will be analyzed using a FACScan flow cytometer, which will count the number of cells that have been activated in each subtype of the immune cell and overall action. Blood will also be analyzed for cortisol levels and inflammatory cytokines, (IL-1, IL-6 and TNF-alpha) using the ELISA assay procedure.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97201
        • Helfgott Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy adults, not pregnant

Exclusion Criteria:

  • Fear or aversion to needles or blood draws.
  • Recent infection or immunocompromised.
  • Allergy to cow's milk.
  • Known herb allergies.
  • Aversions or medical contraindications to alcohol.
  • Medication contra-indications, such as: benzodiazepines, CNS depressants,immunosuppressants and thyroid hormone and supplements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Receives Ashwagandha herb.
Dietary supplement: Ashwagandha
Participants consume 3mL of Ashwagandha for 5 days. Blood work/immune cells (CD4 T-cells, CD8 T-cells, B-cells, NK cells, macrophages, IL-1, IL-6 and TNF-alpha) and psychological assessments (POMS and STAI Self-Evaluation) given at specified time intervals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary endpoint of this study will be to measure immune cell activation, inflammatory cytokines and cortisol levels after administration of the herb.
Time Frame: 24 hours and again at 5 days
24 hours and again at 5 days

Secondary Outcome Measures

Outcome Measure
Time Frame
The secondary endpoint of this study will be to measure and correlate stress levels to the use of the herb.
Time Frame: 24 hours and again at 5 days
24 hours and again at 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University of Natural Medicine

Collaborators

Helfgott Research Institute

Investigators

  • Principal Investigator: Heather Zwickey, PhD, Helfgott Research Institute at NCNM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

January 2, 2009

First Submitted That Met QC Criteria

January 2, 2009

First Posted (Estimate)

January 6, 2009

Study Record Updates

Last Update Posted (Estimate)

March 18, 2010

Last Update Submitted That Met QC Criteria

March 17, 2010

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02202007A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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